Daiichi Sankyo (OTCPK:DSNKY) and commercialization partner AstraZeneca (NYSE:AZN) announce that
the FDA has accepted for review the marketing application for
antibody-drug conjugate (ADC) [fam-] trastuzumab deruxtecan (DS-8201)
for HER2-positive metastatic breast cancer. Under Priority Review
status, the agency’s action date is in Q2 2020.
The companies are jointly developing and
commercializing the product globally (expect Japan where Daiichi has
exclusive rights) under a March 2019 agreement.
https://seekingalpha.com/news/3506446-fda-accepts-application-astrazeneca-daiichi-adc-breast-cancer
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